Friability tester Operation and calibration

1.0 OBJECTIVE :

To define the procedure for calibration and operation of friability tester.

2.0 SCOPE :

This SOP is applicable for operation and calibration of friability tester apparatus (Electrolab make) in quality control department.

3.0 RESPONSIBILITY :

Quality control Chemist and above

4.0 ACCOUNTABILITY:

Quality Control Head

5.0 PROCEDURE :

5.1 Safety and precaution :

Make sure that the knob is properly fitted on the shaft after loading drum.

Do not hold drums while rotating.

Do not use wet drums.

Do not use abrasive material or solvent to clean and dry the drums.

5.2 Procedure for Operation of Friability tester apparatus :

Ensure that friability tester is cleaned, load the first drum on the shaft such that pin on the drum enters into the hole of the bosch.

Place the second drum such that the pin on the drum enters into the hole provided on the first drum.

Insert the knob on the shaft after the drum loading is over. Press the knob till you hear the click sound.

Insert the trays in the tray holders.

After the set up, switch “ON” the mains drum will initialize itself to the loading position and the display shows ‘START’.

Weigh the tablets to be tested and slide them gently into the drum from the side slit provided on the drum.

Select the “TIME MODE” and “REVOLUTION COUNT MODE” as desired by pressing “TIME/COUNT” key respectively.

Enter the desired value for selected mode and press “ENTER” key to register the value.

Press “RUN/HALT” key to start the test and ensure that the display shows elapsed time or count depending on the mode selected.

When the test is over the drum rotates in the reverse direction and discharges the tablets in the tray. Wait till you hear an audible beep and the display shows “END”.

Remove any loose dust from tablets and accurately weigh. Find out the percentage of weight loss of tablets tested.

The drum would initialize itself to loading position and the display will show ‘Start’ indicating that the instrument is ready for the next test.

After completion of the analysis, the results are entered in the raw data by that particular analyst.

The respective data is reviewed by lab location head or his/her designee of that particular lab location.

After completion of test clean the friability tester by using cleaned and dry lint free cloth. open the drum of friability tester and remove the dust and clean the drum by using cleaned and dry lint free cloth.

5.3 Calibration of Friability tester apparatus :

Ensure that friability tester is clean. Switch “ON” the main power supply.

Drum will initialize itself to the loading position at the power “ON”.

Display will show start.

Select the “TIME MODE” as desired by pressing “TIME” key. Display will show the previous time, enter the desired value (time) by using numerical key and press “ENTER” key to register the value.

Select the “REVOLUTION COUNT MODE” as desired by pressing “COUNT” key. Display will show the previous count, enter the desired value (count) by pressing numerical key and press “ENTER” key to register the value.

Press “RUN/HALT” key to start the rotation.

Calibrate the revolution manually by using calibrated stop watch, before pressing the “RUN/HALT” Key of friability tester set the zero reading of stop watch by pressing “SPLIT/RESET” key of stop watch.

Press Simultaneously “RUN/HALT” key of friability tester and “START/STOP” key of calibrated stop watch. Record the reading observation and note down in calibration format.

Perform the calibration for 25 Rotation per minute and 100 Rotation for four minute and record the observation in calibration format. Calculate the average of 100 Rotation and record the reading in calibration format.

Acceptance Criteria:

Rotation per minute should be 25 ± 1 rotation.

Rotation for four minute should be 100 ± 2 rotations.

FREQUENCY : Quarterly

6.0 ABBREVIATIONS:

Abbreviation Expanded form

SOP Standard Operating Procedure

QA Quality Assurance

QC Quality Control

RPM Rotation Per Minute

7.0 ANNEXURES:

Annex. No. Title